Methods of Treating the Sacroiliac Region of a Patient&#39;s Body

ABSTRACT

A method, system and apparatus are disclosed for performing an electrosurgical treatment procedure on a bodily tissue. An electrosurgical apparatus is described, the apparatus comprising one or more probes having insulated and conductive regions for creating lesions in bodily tissue. A method of delivering energy to a patient&#39;s body is described, including methods of treating sacro-iliac related pain using electrosurgical probes.

REFERENCES TO PARENT AND CO-PENDING APPLICATIONS

The present application is a divisional application of U.S. Ser. No.14/270,668, filed on May 6, 2014, which is a divisional application ofU.S. patent application Ser. No. 11/428,458, filed Jul. 3, 2006, whichis a continuation-in-part of co-pending U.S. patent application Ser. No.11/381,783, filed May 5, 2006, which is a continuation-in-part of U.S.patent application Ser. No. 11/356,706 filed Feb. 17, 2006 (now U.S.Pat. No. 8,951,249), which is a continuation-in-part of U.S. patentapplication Ser. No. 11/280,604, filed Nov. 15, 2005 (now U.S. Pat. No.7,819,869); and U.S. patent application Ser. Nos. 11/105,527,11/105,490, and 11/105,524, all filed on Apr. 14, 2005, and which areall continuations-in-part of U.S. patent application Ser. No. 10/087,856(now U.S. Pat. No. 6,896,675) filed on Mar. 5, 2002. In addition, thisapplication claims the benefit of: U.S. provisional application No.60/595,426, filed Jul. 4, 2005; U.S. provisional application No.60/595,559, filed Jul. 14, 2005; U.S. provisional application No.60/595,560, filed Jul. 14, 2005; U.S. provisional application No.60/743,511 filed Mar. 16, 2006; and U.S. provisional application No.60/743,663, filed Mar. 22, 2006. The aforementioned applications are allincorporated herein by reference in their entirety.

TECHNICAL FIELD

The invention relates to an apparatus for creating a lesion to treattissue and a method of using the apparatus to treat a target site.

BACKGROUND OF THE ART

Ablation of nerves is a common practice in the treatment of pain, and iscurrently used to treat back pain in the disc and in the facet joint.Ablation involves the heating of a tissue by the application of energy,in order to create a lesion; it is theorised that the lesioning ofnerves renders them unable to transmit neural signals, thus eliminatingnociceptive sensations therefrom. One common method of ablation involvesthe application of electrical energy from an electrode. Monopolarapparatuses use a grounding pad and a single electrode (or a group ofelectrodes at the same potential), whereby the electrical field isconcentrated around the electrode(s) to generate heat within the tissue.Bipolar or multipolar apparatuses also exist, whereby the electricalcurrent passes substantially between the electrodes, allowing a lesionto be created around each and, depending on the voltage or power used,extending between the electrodes.

Recently, research has led to growing interest in pain emanating fromthe sacroiliac (SI) joint and the surrounding region. Pain associatedwith the SI joint and surrounding region—which has been referred to inthe literature as sacroiliac syndrome, sacroiliac joint dysfunction orsacroiliac joint complex (SIJC) pain amongst other terms—will, forclarity, be referred to throughout this specification as sacroiliacjoint syndrome (SIJS). Referring to FIG. 1, the SI joint 110 is theregion of a patient's body located between the sacrum 100, a large boneat the base of the spine composed of five fused vertebrae, and the ilium102 of the pelvis. SI joint 110 is a relatively immobile joint, servingto absorb shock during locomotion. The structure of the SI joint variessignificantly between individuals but generally comprises an articularcartilaginous surface, a ligamentous aspect and, in most cases, one ormore synovial recesses. Historically, it was believed that SI pain wasreferred, and that the joint itself was not innervated, however, it hasrecently become accepted that nerves do enter the joint. Though thespecific pathways of innervation have not yet been elucidated, thenerves responsible for SI pain are thought to comprise, at least inpart, nerves 106 emanating from the sacral dorsal plexus, the network ofnerves on the posterior surface of the sacrum, extending from theposterior primary rami or sacral nerves 108 that exit the sacralforamina 107. Diagnostic criteria for SIJS include (1) pain in theregion of the SI joint with possible radiation to the groin, medialbuttocks, and posterior thigh, (2) reproduction of pain by physicalexamination techniques that stress the joint, (3) elimination of painwith intra-articular injection of local anesthetic and (4) an ostensiblymorphologically normal joint without demonstrable pathognomonicradiographic abnormalities.

While mechanical support devices exist for the alleviation of pain,there is currently no standardized method or apparatus for the treatmentof SIJS. Yin et al. (Sensory Stimulation-Guided Sacroiliac JointRadiofrequency Neurotonomy: Technique based on Neuroanatomy of theDorsal Sacral Plexus; (2003) SPINE, Vol. 28, No. 20, pp. 2419-2425,which is incorporated herein by reference) suggest treatment of SIJS bylesioning a single branch of a sacral nerve as it exits the sacralforamina. The procedure described by Yin et al. may require a relativelyskilled user due to the approach involved. In addition, the proceduredetailed therein is time consuming as it involves multiple steps ofprobe re-positioning and neural stimulation in order to locate a singlesymptomatic nerve branch.

BRIEF DESCRIPTION OF THE DRAWINGS

In order that the invention may be readily understood, embodiments ofthe invention are illustrated by way of examples in the accompanyingdrawings, in which:

FIG. 1 shows a partial plan view of the sacro-iliac region of a human;

FIG. 2 shows a schematic block diagram of an embodiment of the apparatusof the present invention having 3 probes;

FIG. 3 is a side view of one embodiment of a probe of the presentinvention;

FIGS. 4A and 4B show side views of alternate embodiments of the presentinvention having 3 probes;

FIGS. 5A, 5B, 5C, and 5D are schematic top plan views illustratingembodiments of a method of the present invention;

FIG. 6 is a perspective view showing one embodiment of a lesion locatedwithin a sacral neural crescent.

DETAILED DESCRIPTION OF THE INVENTION

With specific reference now to the drawings in detail, it is stressedthat the particulars shown are by way of example and for purposes ofillustrative discussion of some embodiments of the present inventiononly, and are presented in the cause of providing what is believed to bethe most useful and readily understood description of the principles andconceptual aspects of the invention. In this regard, no attempt is madeto show structural details of the invention in more detail than isnecessary for a fundamental understanding of the invention, thedescription taken with the drawings making apparent to those skilled inthe art how the several forms of the invention may be embodied inpractice.

Before explaining at least one embodiment of the invention in detail, itis to be understood that the invention is not limited in its applicationto the details of construction and the arrangement of the components setforth in the following description or illustrated in the drawings. Theinvention is capable of other embodiments or of being practiced orcarried out in various ways. Also, it is to be understood that thephraseology and terminology employed herein is for the purpose ofdescription and should not be regarded as limiting.

In a broad aspect, the present invention includes an apparatus fordelivering energy to a target site within the body and a method forusing the apparatus to treat a target site, for example to treat paindue to SIJS.

As shown in FIG. 2, an embodiment of a system 200 of the presentinvention for treating at least a portion of a target site 202 in apatient's body may comprise an embodiment of an apparatus of the presentinvention including at least one probe 204 and an energy source 206 forsupplying energy to at least one of probes 204. In the context of thepresent invention, the term ‘probe’ is used to describe any elongatedevice that may be percutaneously inserted into a patient's body. Thesedevices include but are not limited to catheters, cannulae andelectrosurgical probes. For the sake of clarity, the term ‘probe’ isused throughout the specification to describe any such device.

Some embodiments of a probe 204, as shown for example in FIG. 3,comprise an elongated shaft 300 with a distal region 302 and a proximalregion 304. As used herein, the term ‘proximal’ is used to refer to aportion or region of a device or tissue that is located closer to theuser of the device. ‘Distal’ refers to a portion or region of a deviceor tissue that is located closer to a treatment site and further awayfrom the user. At least a portion 306 of distal region 302 iselectrically conductive and exposed, and this conductive region 306 maybe electrically coupled to energy source 206, thus allowing energy to bedelivered to target site 202 via probe(s) 204. In some embodiments, theentire shaft 300 of probe 204 is made from a conductive material, whichis overlain with an electrically insulating coating. In otherembodiments, shaft 300 is made from an insulating material, with atleast one conductive region 306 being affixed within or overtop ofdistal region 302 of shaft 300. In some embodiments, one or more probes204 may be furnished with an insulating coating on one side of probe 204at distal region 302, adjacent to conductive region 306 for directingcurrent flow. Examples of such embodiments are provided in U.S. patentapplication Ser. No. 11/381,783, filed May 5, 2006, incorporated hereinby reference.

Proximal region 304 of shaft 300 may comprise a handle 308 and one ormore connector means 310 for connecting to energy source 206 or toanother device such as a measuring device or a cooling means, forexample a fluid delivery device. Connector means 310 may comprise one ormore electrical cables or wires, one or more electrical connectorsand/or one or more flexible tubes. Probe(s) 204 may have a variety ofcharacteristics, for example: any of probes 204 may be straight or mayhave one or more bends anywhere along its length or may have a shapethat is able to be changed, either manually or automatically. In thecontext of the present invention, the term ‘bent’ is used to describeany deviation from a longitudinal axis, whether it be a gradual or anabrupt deviation, and including all angles of deviation. Furthermore,distal regions 302 of probes 204 may be blunt, sharp, or pointed, or maytake on any other shape; probes 204 may be solid in some embodimentsbut, in alternate embodiments, may be hollow and may define one or morechannels or lumens. All probes 204 may have common characteristics, ormay differ in terms of one or more characteristics; for example, thesize of conductive region 306 may differ between the probes.

Probes 204 may be configured to deliver energy in a variety ofconfigurations, for example, in a monopolar configuration, whereby allprobes 204 are at the same electrical potential and energy may bedelivered via probes 204 through a patient's body to a separate returnelectrode, or in a bipolar configuration, whereby energy flowssubstantially between two or more probes 204 or between two or moreelectrodes on one probe 204. If two or more probes 204 are used in abipolar configuration any probe 204 may be an active or a returnelectrode. In further embodiments, probes 204 may be configured in amultipolar or multiphasic arrangement, whereby the probes 204 areconfigured such that the electrical potential and/or the phase of energytransmitted to at least two of the probes differs in such a way to causeenergy to flow in a desired direction between the probes. Additionally,in order to direct the current to flow preferentially to a certain probe204 or between a certain pair of probes 204, a resistance or impedancebetween energy source 206 and one or more probes 204, or between one ormore probes 204 and a current sink (such as the circuit ‘ground’) orbetween two or more probes 204 may be varied. In other words, if itwould be desirable to have current flow preferentially to a first probe,then the impedance between energy source 206 and any other probes may beincreased so that current will flow preferentially to the first probe.Similarly, it may be desirable to have current flow between two or morespecific probes. For example, a first and a second probe may be coupledto a first electrical pole while a third probe may be coupled to theopposite pole. Thus, current may flow between the third probe and eitherthe first or second probe. If it would be desirable to have current flowbetween, for example, the third probe and the first probe, then animpedance between the second probe and circuit ‘ground’ may be increasedso that current flows preferentially between the third and first probes.Thus, the flow of current to each of probes 204 may be independentlyadjustable by, for example, varying the impedance as mentioned above. Inaddition, flow of current to each probe 204 may or may not beconcurrent. Thus, all probes 204 may be ‘on’ (i.e. transmitting orreceiving current) at the same time or one or more probes 204 may be‘on’ while other probes 204 are ‘off’ (i.e. not transmitting orreceiving current). This may be implemented, for example, by usingtime-division multiplexing or various other switching means. Furtherdetails regarding the control of energy delivery to or between multipleprobes are provided in U.S. patent application Ser. Nos. 11/105,527,11/105,490, and 11/105,524, all filed on Apr. 14, 2005, all of which areincorporated herein by reference.

In embodiments having multiple probes 204, the probes 204 may bephysically connected to form an attached probe assembly, for example, byhaving handles 308 of each probe attached to a common stage (not shown).Such a stage may be adjustable, so that the positions of probes 204 maybe changed, relative to one another, for example, by being furnishedwith hinges or moveable components.

In one embodiment, as shown for example in FIG. 4A, the apparatus of thepresent invention comprises two probes 400, each measuring between about60 mm to about 80 mm in length with a diameter between about 0.9 andabout 1.3 mm, and a conductive region 306 at the distal tip about 1.5 toabout 2.5 mm in length; and one probe 402 measuring between about 60 mmand about 80 mm in length with a diameter between about 0.9 and about1.3 mm, and a conductive region 306 at the distal tip about 2 mm toabout 4 mm in length. The probes may be arranged in a bipolarconfiguration, such that when energy is supplied to probes 400 fromenergy source 206, energy travels preferentially between each of probes400 and probe 402, rather than between probes 400. Because probe 402 isreceiving RF current from both probes 400, the conductive region ofprobe 402 may be larger, in order to maintain the current density aroundprobe 402 at a level similar to that around each of probes 400.Depending on the distance between the probes, and on the properties oftarget site 202, one or more lesions may be created between each ofprobes 400 and probe 402.

In another embodiment, shown in FIG. 4B, the apparatus of the presentinvention comprises three probes 400, each measuring between about 60 mmto about 80 mm in length with a diameter between about 0.9 and about 1.3mm, and a conductive region 306 at the distal tip up to about 6.5 mm inlength, more specifically about 4 mm in length. The probes may beconfigured in a monopolar configuration, such that when energy issupplied to probes 400 from energy source 206, the energy isconcentrated around each of probes 400. Alternatively, the probes may beconfigured in a bipolar or multipolar configuration. Probes 400 may beseparated by a distance such that energy delivery to one probe doesn'tinterfere with energy delivery to another probe in embodiments whereenergy is delivered to two or more probes substantially concurrently.For example, in embodiments wherein the three probes 400 are coupled toa stage, each probe 400 may be separated by a distance of about 5 timesthe diameter of the probes, i.e. about 4.5 to about 6.5 mm, for exampleabout 5 mm. In further embodiments, the probes may be separated by alarger distance, for example about 5 to about 15 mm, more specificallyabout 10 mm. In embodiments of the apparatus comprising one or morecooled probes, the separation distance between probes 400 may be evengreater, in order to account for the fact that the effective radius ofenergy delivery is increased due to the cooling as described furtherherein below. In such embodiments, the probes may be separated, forexample, by a distance of about 10 to about 20 times the diameter of theprobes, i.e. about 13 to about 26 mm, more specifically about 15 mm.

It will be appreciated that the specific measurements and dimensionsreferred to herein are by way of example only and are not intended to belimiting. Such measurements and dimensions can be selected by a personof ordinary skill in the art as appropriate for any particularapplication of the invention.

In some embodiments the conductive and exposed portion at the distal endof the probe may comprise only the distal face of the probe. Forexample, if the distal end is substantially rounded (as shown in FIG.3), the distal hemisphere may remain exposed, while if the distal end isflat (not shown) the distal face or surface may remain exposed. Furtherdetails regarding such embodiments are provided in U.S. ProvisionalPatent Application 60/743,511 filed on Mar. 16, 2006, incorporatedherein by reference. Such embodiments may be operable (with or withoutcooling) to form a lesion substantially distal to the tip of the probe,which may be desirable when employing a substantially perpendicularapproach to a target site as disclosed herein below.

The probes may be configured to deliver high-frequency energy (such asradiofrequency (RF) energy) supplied by an energy source 206, forexample a generator. One potential benefit of supplying high-frequencyenergy is that the high-frequency signal provides deeper tissuepenetration than a typical DC or lower frequency signal. Depending onthe voltage delivered to the target site 202 via the probes, the energymay generate sufficient heat in the tissue to cause lesions due toablation or coagulation. In the context of the present invention,‘ablation’ refers to raising the temperature of a tissue such that atleast a portion of the tissue is coagulated and a lesion is formedwithin the tissue. A further benefit of using high-frequency energy isthat it may allow for the creation of repeatable lesions. An additionalbenefit is that the frequency of the high-frequency energy is beyond thephysiological range in the human body so that other organs, which uselower frequency signals, are not affected by this high-frequency signal.In alternate embodiments, other forms of energy may be delivered,including microwave energy, ultrasonic energy, thermal energy or opticalenergy (for example, via a laser).

Additionally, in some or all of the embodiments of the presentinvention, the apparatus may comprise one or more of: means for coolingthe tissue adjacent a region of one or more probes 204 (for example, bythe circulation of a cooling fluid through an internal lumen of theprobe), means for changing the shape of at least a portion of one ormore probes 204 (for example, using a spring or a guide wire or othermeans of actuation), means for facilitating the insertion of one or moreprobes 204 into a patient's body (for example, an introducer apparatuscomprising a cannula and/or an obturator/stylet), means for visualizingone or more probes 204 once they have been inserted into a patient'sbody (for example, using a radiopaque marker in conjunction withfluoroscopic imaging or using some other imaging modalities), othertactile or visual markers and one or more additional functional elementsfor performing a procedure on the tissue (such as adding or removingmaterial). As has been mentioned, probes 204 may be substantially rigidor may have various degrees of flexibility. Furthermore, one or moreregions or segments of probes 204 may be manually or automaticallydeformable or steerable.

The use of cooling in conjunction with the delivery of energy to thetarget site may reduce the temperature of the tissue in the vicinity ofthe probe, where the most energy is delivered, allowing more energy tobe delivered without causing an unwanted increase in local tissuetemperature. Increasing the energy delivered to the tissue allowsregions of the tissue further from the probe to reach a temperature atwhich a lesion can form, thus increasing the total maximum lesionvolume. This may allow for probes to be placed further away from eachother while maintaining sufficient temperatures between the probes tocreate a lesion between the probes. Further details regarding cooledprobes are provided in U.S. patent application Ser. Nos. 11/105,527,11/105,490, and 11/105,524, all filed on Apr. 14, 2005 and in U.S.Provisional Patent Application 60/595,559, filed Jul. 14, 2005;60/595,560, filed Jul. 14, 2005; and 60/743,511, filed Mar. 16, 2006,all of which are incorporated herein by reference.

Embodiments of the apparatus of the present invention may furthercomprise a means for measuring one or more tissue properties, includingbut not limited to temperature and impedance. The apparatus may furthercomprise means of measuring pressure or other physical properties. Themeans of measuring temperature may comprise at least one thermocouple,thermistor or thermometer located anywhere along the length of one ormore probes 204, or extending from one or more probes 204. The means ofmeasuring pressure may comprise a lumen in fluid communication with anexternal environment as well as with a pressure transducer for recordingpressure measurements. In other embodiments, the pressure measuringmeans may comprise a pressure transducer disposed at a desired locationon the probe. Impedance may be monitored or measured by using acomponent of the apparatus as part of an impedance measuring circuit.For example, in embodiments of the present invention that employ morethan one probe 204, the probes 204 used during the course of a treatmentprocedure may form part of the circuit of an electrical impedance meter,wherein energy may be transmitted between the probes 204 through aregion of tissue, allowing a user to determine the impedance of saidregion of tissue. This feature may be useful to determine whether or notthe impedance of the tissue lies within a ‘normal’ range—if theimpedance of the tissue is found to be outside that range, it may beindicative of an injury or defect within the tissue. As mentioned above,a single probe 204 may also have an impedance measuring capability, forexample to help determine the location of the probe 204 within apatient's body.

A means for measuring one of the properties mentioned above mayoptionally be used in conjunction with a means for controlling theoperation of the apparatus based on said measured properties. Forexample, in one embodiment, at least one of probes 204 comprises atleast one temperature sensor operatively connected to a controller,whereby the supply of energy to at least one probe 204 can be controlledby the controller based on the measurements received from the at leastone temperature sensor. The controller may be in electricalcommunication with energy source 206, such that for example, if themeasured temperature exceeds a specified upper threshold, the controllermay perform a specified action, including but not limited to shuttingdown energy source 206 or decreasing the power delivered to probes 204from energy source 206. In an alternate embodiment, the apparatuscomprises impedance sensors which are connected to a controller andwhereby the supply of energy may be controlled by the controller basedon the measurements received from the impedance sensors. In additionalembodiments, the operation of the apparatus may be modified in otherways, including but not limited to, terminating a treatment procedure,modifying the supply of a cooling means to one or more probes 204, oraffecting a change in the conductivity or impedance of one or moreprobes 204. The operation of apparatus 200 may also be able to bemanually controlled by a user, or may be automatically controlled basedon other parameters, for example, based on a measurement of a propertyof a component of the apparatus itself, rather than a property of thetissue. Means of controlling the operation of the apparatus of theinvention may optionally be configured to independently control one ormore probes 204. As has been mentioned, current flow to any of probes204 may be independently adjustable. In addition, the flow of coolingmay be controlled independently to each probe 204. Thus, if one probe204 is found to be at a higher temperature relative to other probes 204,flow of cooling to that probe 204 may be increased. Similarly, if oneprobe 204 is found to be at a lower temperature relative to other probes204, flow of cooling to that probe 204 may be decreased.

Additionally, energy source 206 may be operable to supply stimulationenergy to the body, whereby energy is delivered to target site 202 viaone or more probes 204 at a frequency suitable for stimulating amuscular, sensory, or other response in the tissue. The effects ofstimulation may be observed directly, such as visual observation of amuscle twitch or report of pain by the patient, or may be measured by anappropriate sensing means, for example an electromyogram (EMG) orsomato-sensory evoked potential (SSEP) electrode, to measure thestimulation of muscle tissue. In accordance with embodiments of thepresent invention, stimulation of tissue may beneficially be practicedusing the same apparatus configuration as is used to deliver energy forablation/lesioning. In other words, the apparatus configuration used toablate tissue may beneficially be used to stimulate tissue as well. Forexample, in one embodiment of the present invention as mentioned above,apparatus 200 is configured such that probes 400 and 402 form a pair ofbipolar probe assemblies so that two lesions may form between each ofprobes 400 and probe 402. In such an embodiment, stimulation of tissuemay be performed in a dual-bipolar fashion, wherein probes 400 and 402form a pair of bipolar probe assemblies and wherein stimulation energyis delivered between each pair of bipolar assemblies. Alternatively,stimulation may be performed in a monopolar fashion, wherein stimulationenergy is delivered between a probe and a dispersive electrode, forexample a grounding pad, if the apparatus is configured to delivertreatment energy in such a manner. Thus, it may be desirable to performa stimulation procedure using the same configuration to be applied in atreatment (i.e. lesioning/ablation) procedure in order to ensure thesafety of the treatment procedure.

According to one embodiment of the present invention, probes 204 arefabricated from stainless steel. However, any biocompatible andconductive material, including but not limited to nickel-titaniumalloys, may be used, depending on the desired structural properties ofthe probe. For example, in applications requiring a stiffer and strongerprobe, stainless steel may be desirable, while nickel-titanium alloy maybe used for applications requiring superior flexibility and/or shapememory. In alternate embodiments, as previously described, probes 204may be manufactured from a non-conductive material including, but notlimited to, polytetrafluoroethylene (PTFE), polyvinylchloride (PVC) orpolyurethane, and a conductive region 206 may then be incorporated intoor onto probes 204. The insulating material, used to insulate probes204, may beneficially comprise PTFE, polyimide or paralene, but anyinsulating material, including but not limited to polyethyleneterephthalate (PET), may be used and the invention is not limited inthis regard. For example, in alternate embodiments, the insulatingmaterial may be semi-porous or partially conductive to allow for someleakage of current through the insulating material. It should be notedthat different insulating materials can be used for different portionsof probes 204 and the invention is not limited in this regard.

In one broad aspect, the present invention may provide a method fortreating the sacroiliac region of a patient's body by delivering energy.In one embodiment, the method may comprise the steps of: inserting oneor more probes into the sacroiliac region of a patient's body, whereinthe one or more probes are inserted at an angle ranging between about45.degree. to about 135.degree. relative to a face of a foramen to oneor more target sites; and delivering energy from an energy sourcethrough the one or more probes to the target site(s). In a further broadaspect, the method of treating at least one target site in a sacroiliacregion of a patient's body by delivering energy, the method comprisesthe steps of: inserting one or more probes into the sacroiliac region ofa patient's body, wherein the one or more probes are inserted so as tobe generally upstanding relative to a face of a foramen; and deliveringenergy from an energy source through the one or more probes to the atleast one target site. The target site may for example be at least aportion of the sacroiliac region of a patient's body. In anotherembodiment, the method may comprise the steps of: inserting one or moreprobes into the sacroiliac region of a patient's body, wherein at leastone of the one or more probes are positioned at least 1 cm lateral to aposterior sacral foramen; and delivering energy from an energy sourcethrough the one or more probes to at least one target site within thesacroiliac region of a patients body. In the context of the instantdisclosure, the sacroiliac region refers to the region of the patient'sbody comprising the sacrum and ilium and their articulation (includingthe sacroiliac joints) or associated ligaments.

One general application of a method aspect of the present invention isfor the creation of one or more lesions at a target treatment site in apatient's body, for example within the sacroiliac region. If asufficient amount of energy (for example, about 1 to about 10 Watts and,in some embodiments, about 2 to about 5 Watts) is delivered to a regionof tissue using the apparatus of the present invention, at a sufficientvoltage (for example, about 10 to about 160 Volts and, in someembodiments, about 10 to about 65 Volts) to increase the heat of thetissue to or past the ablation temperature of the tissue (typicallyabout 42.degree. C.), ablation will occur and one or more lesions willform. This ablation can include, but is not limited to, ablation of oneor more of neural tissue, whose ablation can prevent the transmission ofnociceptive sensation, structural or connective tissue, whose ablationcan cause a contraction of collagen and a reduction in the volume oftissue, and vascular tissue, whose ablation may result in the disruptionof nutrient supply to one or more neural structures. The specificgeometry of the components of the apparatus, the positions anddimensions of the probes and the presence, absence and/or degree ofcooling may affect the shape and size of any resulting lesions.

In accordance with one application of a method aspect of the presentinvention, a method is provided for the treatment of SIJS by creatingone or more lesions to ablate nerves emanating from the posterior sacralforamina that innervate the SI region. This approach may be beneficialbecause it may allow for a treatment procedure that can effectivelytarget neural tissue that innervates the SI joint without having toactually enter the joint itself. Furthermore, if a patient's pain isemanating from the SI ligaments, it may be beneficial to target theneural tissue before it reaches the ligaments in order to alleviate thispain. Generally, it may be beneficial to treat neural tissue as close tothe nerve root as possible, in order to increase the effectiveness ofthe treatment procedure.

In one embodiment, it may be desired to treat one or more neuralstructures within a sacral neural crescent 506. The term ‘sacral neuralcrescent’ refers to an area lateral to each of the sacral foramina,through which the sacral nerves are believed to pass after exiting theforamina. On the dorsal right side of the sacrum, this window is fromabout 12 o′clock to about 6 o′clock in a clockwise direction, while onthe dorsal left side of the sacrum the window is from about 6 o′clock toabout 12 o′clock in a clockwise direction. Similar (but in thecounter-clockwise direction) areas exist on the ventral side of thesacrum. The clock positions are referenced as if the foramen is viewedas a clock face, and the view is taken looking towards the sacrum. Forreference, the 12 o′clock position of the clock face would be the mostcephalad (towards the head) point of the foramen. Alternatively, theneural tissue may be treated at some position between a lateral edge ofa sacral foramen and a margin of an SI joint. In some embodiments, theprobe(s) used in this method aspect of the present invention may beoperable to treat a plurality of neural structures without the need forone or more of removal of the probe(s), reinsertion of the probe(s) orrepositioning of the probe(s). For example, at least two branches of thesacral nerves may be treated. These two branches may comprise two ormore branches of the same sacral nerve or at least one lateral branchfrom one sacral nerve and at least one lateral branch from a differentsacral nerve.

Thus, some embodiments of a method aspect of the present invention maygenerally comprise the steps of inserting one or more probes into aregion of tissue adjacent one or more sacral foramina and deliveringenergy through the probe(s) in order to relieve symptoms of SIJS,wherein the energy may be delivered in order to ablate tissue. Theenergy may be delivered in a monopolar, bipolar, multipolar ormultiphasic manner. When more than one probe is used, each of the probesmay be independently controlled. For example, the temperature at thedistal end of each of the probes may be monitored, and the powerdelivered to each of the probes may be adjusted based on the temperatureof each of the probes. Two specific examples of such embodiments will bepresently described.

In one specific embodiment of this aspect of the present invention shownin FIG. 5A, two probes 400 having conductive tips 306 of equal lengthand one probe 402 having a longer conductive tip are inserted lateral toa sacral foramen, more specifically, within a sacral neural crescent506. In some embodiments, the probes may be positioned to be generallyupstanding or substantially perpendicular relative to the circular faceof foramen 500 (i.e. the surface of the sacrum or sacral plate), and insome embodiments the probes may be positioned such that at least aportion of the target site is generally distal to the distal ends of theone or more probes. For example, the shaft of the probes may be at anangle of between about 80.degree. to about 100.degree., relative to thecircular face of foramen 500, or alternatively, in some embodiments, theangle between the probe shaft and the face of the foramen may be betweenabout 60.degree. to about 120.degree., or in alternate embodiments,between about 45.degree. to about 135.degree., i.e. relative to thecircular face of the foramen. The probes may be operable in adual-bipolar configuration, whereby probes 400 lie at a first electricpotential and probe 402 lies at a second electric potential such thatcurrent flows substantially between each probe 400 and probe 402. Inother embodiments, an alternate number of probes may be used, forexample five probes may be used, three of which may lie at a firstelectric potential, and two of which, alternating between the firstthree probes, may lie at a second electric potential, as shown in FIG.5C. It will be appreciated that in other embodiments the angle betweenthe probe shaft and the face of the foramen may vary from the rangesreferenced above.

The step of inserting one or more probes adjacent one or more sacralforamina may comprise visualizing a foramen 500 adjacent to a targetsite, for example using fluoroscopic imaging, penetrating into thetissue overlaying the sacrum using one or more rigid introducerapparatuses or other insertional means, and inserting the probes throughthe insertional means. In embodiments using multiple probes that arecoupled, for example to a stage or other probe assembly, as describedabove, the step of visualization may be followed by a step of adjustingthe positions of the probes relative to the assembly prior to insertionof the probes. Thus, the probe(s) may be inserted substantiallyconcurrently, for example by using a probe assembly to which the probesare coupled, or they may be inserted sequentially, for example one at atime. The probes may be inserted substantially perpendicularly to thecircular face of the foramen, such that when visualizing the foramenusing a fluoroscope or x-ray, visualization of the probes will be alongthe length of the probe shaft, in a “gun barrel” view; this angle ofapproach may potentially minimize tissue damage during insertion as aminimal amount of tissue will need to be penetrated, and may also aid inproper positioning of the probes. Penetration into the tissue may alsobe facilitated by the use of sharp or pointed probes, by the use of anobturator/stylet, by the insertion of a guide wire or by any otherinsertional means (i.e. means for insertion) and the invention is notlimited in this regard. It should also be noted that the introducer(s)or other insertional means may be electrically and/or thermallyinsulated and they may be bent or straight. Furthermore, the length anddiameter of the insertional means are not limited to specific values andany suitably sized introducer may be used. For clarity, the termintroducer will be used throughout this specification and is intended toencompass any means for insertion that may facilitate entry of a probeinto a specific site within the body of a patient. In such embodiments,these introducers may be capable of penetrating into a patient's body aswell as penetrating through one or more of the ligaments of thesacroiliac region. In alternate embodiments, a probe may be positionedat the appropriate location within a patient's body without using anyadditional means to facilitate insertion.

Thus, in this embodiment of this aspect of the present invention, andwith reference again to FIG. 5A, a method for treating SIJS may bepracticed as follows: a patient is made to lie prone on an operatingtable or similar structure, and local anesthetic is provided in thevicinity of the sacrum. Prior to the insertion of the probe(s) orintroducer(s), fluoroscopic imaging, including, in some embodiments, theinjection of a radiopaque contrast agent, or other means may be used tovisualize a patient's sacroiliac region in order to ascertain a desiredapproach for inserting the device(s) into the desired tissue. This maybe particularly advantageous with respect to SIJS treatment proceduresbecause the anatomical structures involved may vary significantly frompatient to patient. In this embodiment, following visualization to alignthe plane of visualization and foramen 500 adjacent the treatment site,the probes may be inserted radially away from, for example lateral,caudal, or cranial to, the lateral edge of a foramen, for example about6 to about 12 mm, more specifically about 10 mm from the lateral edge.Probe 402, with a relatively larger conductive region, may be placedlateral to the lateral edge of a foramen at approximately the 4 o′clockposition when the foramen is viewed as a clock face. The two probes 400,with relatively smaller conductive regions, may be placed—onesubstantially cranial and one substantially caudal to probe 402—atapproximately the 2 o′clock and 6 o′clock positions, for example about 6to about 10 mm and, more specifically, about 8 mm from the lateral edgeof the foramen. As used herein, the terms ‘substantially cranial’ and‘substantially caudal’ may refer to any position cranial or caudal to areference point, respectively, whether at the same lateral position oranother lateral position. It should be noted that the aforementionedprobe positions relate to a foramen on the right side of the sacrum whenfacing the posterior of the sacrum. For the left-sided foramina, theequivalent positions would be 8 o′clock for probe 402, and 10 o′clockand 6 o′clock for probes 400. Furthermore, depending on the specificanatomy of the patient and the desired lesion shape and location, theprobes may be positioned at other locations, and the invention is notlimited in this regard. For example, in some embodiments, the probes maybe positioned at 1 o′clock, 3 o′clock, and 5 o′clock. In yet furtherembodiments, wherein an alternate number of probes are used, the probesmay be placed at other locations. For example, as shown in FIG. 5C, iffive probes are used, the probes may be placed at 12 o′clock, 2 o′clock,3 o′clock, 4 o′clock, and 6‘o’clock.

In one embodiment of this aspect of the present invention, threeintroducers are inserted into a patient's body from an approach that issubstantially perpendicular to the surface of the target treatment siteadjacent the foramen, such that a distal end of each introducer ispositioned proximate to or adjacent the lateral edge of sacral foramen500. In some embodiments, the distal ends of the introducers and/orprobes are positioned substantially superficial to the sacral bonysurface, such that, in particular embodiments, there are no ligaments orother connective tissue between the distal ends of the introducersand/or probes and the sacrum. In further embodiments, the distal ends ofthe introducers and/or the probes may be placed about 2 to about 6 mmaway from the surface of the sacrum, for example about 4 mm away fromthe surface. For example, an introducer apparatus may be about 2 toabout 6 mm longer than a probe such that, when a distal end of theintroducer is placed adjacent to the surface of the sacrum, the distalend of a probe fully disposed within the introducer may be located about2 to about 6 mm away from the surface. In other embodiments, variousangles of approach and sites of entry may be used. Depending on the siteof entry and the angle of approach that are chosen, the introducer maybe either bent or straight. A bent introducer may take several forms andthe invention is not limited in this regard. For example, it may be bentalong a substantial portion of its length or it may have a bent tip,wherein the rest of the introducer may be straight. At this point, theposition of one or more introducers may be verified using fluoroscopicimaging (or other imaging modalities) or other means, after which theprobes may be inserted through a bore or lumen of each introducer. Theprobes may be positioned at an angle such that the target treatment siteis visualized straight down the shaft of the probes, and the probes mayappear in cross-section, as shown in FIG. 5. It should be noted that, inthose embodiments that comprise a stylet to facilitate positioning ofthe probe, the stylet may be disposed within an introducer and may beremoved from the introducer prior to insertion of the probe.

It is advisable, at this stage, to ascertain the location of one or moreof the probes with respect to any sensory and/or motor nerves that maybe located close to the conductive regions of the probes by stimulatingthe neural tissue at one or more frequencies and determining the effectof said stimulation, as has been described. As mentioned above, thestimulation of neural tissue may be performed in a bipolar manner,wherein energy passes between two or more probes, or in a monopolarmanner, wherein energy passes between one or more probes and adispersive return electrode. Using this step, it can be determinedwhether a target nerve or nerves has a function that wouldcontraindicate its ablation or functional alteration. In thisembodiment, the lack of a contraindication would lead to the step ofdelivering energy, whereas the presence of a contraindication would leadback to the step of inserting a probe or probes, whereby the step ofinserting a probe or probes comprises modifying the position of a probeor probes within the body. Further details regarding stimulation ofneural tissue are provided in U.S. patent application Ser. Nos.11/105,527, 11/105,490, and 11/105,524, all filed on Apr. 14, 2005, andall previously incorporated herein by reference. In alternateembodiments, no stimulation is performed and a user may rely on his orher knowledge, for example of the anatomical features of this region ofthe patient's body, in order to determine whether or not to proceed withthe treatment procedure.

At this point, energy may be delivered from energy source 206 via theprobes to the target treatment site. Referring still to FIG. 5A, energymay be delivered in order to create a lesion lateral to foramen 500,within at least a portion of the sacral neural crescent 506, such thatthe lesion may, in some embodiments, encompass at least one sacral nerveexiting foramen 500 and/or one or more lateral branches of the at leastone sacral nerve. For example, in embodiments utilizing bipolar RF, a“dog bone”-shaped lesion may form between each pair (400, 402) ofbipolar probes, which may result in a lesion 502 as shown in FIG. 5A.

In some embodiments, for example as shown in FIG. 6, the lesion may havea height of about 1 mm to about 15 mm, for example about 8 mm to about10 mm, in order to account for variability in the location of the nervesto be treated in the anterior-posterior plane of the patient's body. Insome embodiments, the user may adjust a parameter of the treatmentprocedure in order to modify the height of the lesion, and therebyincrease the size of the lesion. For example, in order to achieve thedesired lesion height, the probe(s) may be withdrawn slightly from thepatient's body, for example by about 2 mm to about 5 mm, and the step(s)of energy delivery may be repeated. These steps (i.e. withdrawing theprobes and delivering energy) may be repeated until the desired lesionis formed. In some embodiments, any one or more of the probe(s) maycomprise at least two electrodes wherein energy may be delivered betweenthe electrodes in a bipolar manner. In such embodiments, lesion heightor length may be increased relative to a monopolar probe due to the factthat energy will travel further along the length of the probe, betweenthe electrodes. Alternatively, the probe(s) may have longer active tipsin order to form a lesion of a desired height. In such embodiments, theprobe(s) may be operable to create an elongated lesion, for example astrip lesion. For example, the probe(s) may comprise alternating regionsof conductive and non-conductive surfaces, in order to create anelongate, substantially homogeneous lesion. Further details regardingsuch probes are provided in U.S. patent application Ser. No. 11/356,706filed Feb. 17, 2006, incorporated herein by reference. In anotherembodiment, the probe(s) may be structured such that the length of theelectrically exposed active tip may be adjustable; for example, theinsulative coating may be structured, for example as a sheath, to slideback and forth on the shaft of the probe. By sliding the insulationproximally, the user may adjust the electrically exposed length of theactive tip, thus effectively adjusting the height of the lesions thatmay be formed by the tip. In a further embodiment, the height of thelesion may be modified by adjusting an amount of cooling supplied to theprobe. As is disclosed in U.S. Provisional Patent 60/743,511 (filed onMar. 16, 2006), incorporated herein by reference, cooling a probe mayallow for a lesion to form at a position located away from the probe. Bysupplying a high amount of cooling to the probe, a lesion will formsubstantially distally to and remote from the conductive region 306 ofthe probe. If the amount of cooling supplied to the probe is reduced, alesion will form closer to the probe. Thus, by modifying the amount ofcooling supplied to the probe, a lesion may form at various heightsrelative to the probe and the sacrum. As will be described below, energydelivery between the probes may be substantially concurrent or it may besequential, depending, for example, on the number of probes used, theenergy source 206 and the preferences of the user.

Following the step of energy delivery, if one or more of the probes aresteerable, the tips of one or more of the probes may be maneuvered to asecond location and energy may again be delivered to ablate the neuraltissue at the second location. This may be repeated as many times as theuser feels is necessary. If no probes are steerable, the insertion andpositioning steps may be repeated so that one or more of the probes isremoved and reinserted to a second position, at which point energy maybe delivered again at this location. For example, in some embodiments,only two probes may be used, for example one probe 400 and one probe402. In such embodiments, probes 400 and 402 may be placed adjacent tothe foramen as indicated above, for example with probe 400 at the 6o′clock position. After energy delivery has been completed at thisposition, probe 400 may be removed and reinserted into the 2 o′clockposition, leaving probe 402 in place. The step of energy delivery maythen be repeated. Once the user has determined that enough neural tissuehas been ablated, the introducer and the probe may be removed from thebody and the patient should be allowed to recover. It should be notedthat in some embodiments, a step of re-inserting the probe(s) may not berequired. For example, based on the specific anatomy of the patient, theuser may determine, for example by using stimulation, that only aportion of the region surrounding the foramen needs to be ablated inorder to, for example, relieve a patient's pain. In such an embodiment,the user may form a single lesion adjacent the foramen and substantiallybetween two probes. It should be further noted that this description isintended to be exemplary only and that other embodiments are envisionedas well. In addition, this invention is not intended to be limited bythe number and type of probes used in this and other embodiments.

In another embodiment of this aspect of the present invention, as shownin FIG. 5B, three probes 400 may be inserted lateral to a sacral foramen500, in the region of sacral neural crescent 506, such that the probes400 are positioned substantially perpendicularly to the sacrum orgenerally upstanding relative to the sacrum. For example the shaft ofthe probes may be at an angle of between about 80.degree. to about100.degree. relative to the circular face of foramen 500 (the surface ofthe sacrum), or in some alternate embodiments the angle between theprobe shaft and the face of the foramen may be between about 60.degree.to about 120.degree. or, in other alternate embodiments between about45.degree. to about 135.degree. relative to the circular face of theforamen 500. The probes may be operable in a monopolar configuration,whereby each probe 400 lies at the same electric potential such thatcurrent flows substantially between each probe 400 and a dispersiveelectrode such as a grounding pad. In other embodiments, an alternatenumber of probes may be used, and the invention is not limited in thisregard. For example, as shown in FIG. 5D, five probes may be used, allof which may lie at the same electric potential.

As described above with respect to the first embodiment of a methodaspect of the present invention, the step of inserting one or moreprobes adjacent one or more sacral foramina may comprise visualizingforamen 500 adjacent to a target site, for example using fluoroscopicimaging, penetrating into the tissue overlaying the sacrum using one ormore rigid introducer tubes or other insertional means, and insertingthe probes through the insertional means. In embodiments using multipleprobes that are coupled, for example to a stage or other probe assembly,as described above, the step of visualization may be followed by a stepof adjusting the positions of the probes relative to the assembly priorto insertion of the probes. As has been mentioned above, the relativespacing of the probes may be set so that no interference occurs betweenthe probes during energy delivery. Thus, the probe(s) may be insertedsubstantially concurrently, for example by using a probe assembly towhich the probes are coupled, or they may be inserted sequentially, forexample one at a time. In alternate embodiments, a single probe may beused, wherein the probe is reinserted or otherwise repositioned atvarious locations, as described below, in order to create a desiredlesion.

The probes may be inserted substantially perpendicularly to the circularface of the foramen, such that when visualizing the foramen using afluoroscope or x-ray, visualization of the probes will be along thelength of the probe shaft, in a “gun barrel” view; this angle ofapproach may potentially minimize tissue damage during insertion as aminimal amount of tissue will need to be penetrated, and may also aid inproper positioning of the probes. Penetration into the tissue may alsobe facilitated by the use of sharp or pointed probes, by the use of astylet, by the insertion of a guide wire or by any other insertionalmeans (i.e. means for insertion) and the invention is not limited inthis regard. It should also be noted that the introducer(s) or otherinsertional means may be electrically and/or thermally insulated andthey may be bent or straight. Furthermore, the length and diameter ofthe insertional means are not limited to specific values and anysuitably sized introducer may be used. For clarity, the term introducerwill be used throughout this specification and is intended to encompassany means for insertion that may facilitate entry of a probe into aspecific site within the body of a patient. In such embodiments, theseintroducers may be capable of penetrating into a patient's body as wellas penetrating through one or more of the ligaments of the sacroiliacregion. In alternate embodiments, a probe may be positioned at theappropriate location within a patient's body without using anyadditional means to facilitate insertion.

Thus, in one embodiment of this aspect of the present invention, andwith reference again to FIG. 5B, a method for treating SIJS may bepracticed as follows: a patient is made to lie prone on an operatingtable or similar structure, and local anesthetic is provided in thevicinity of the sacrum. Prior to the insertion of probe(s) orintroducer(s), fluoroscopic imaging or other means may be used tovisualize a patient's sacroiliac region in order to ascertain a desiredapproach for inserting the device(s) into the desired tissue. This maybe particularly advantageous with respect to SIJS treatment proceduresbecause the anatomical structures involved may vary significantly frompatient to patient. In this embodiment, following visualization to alignthe plane of visualization and foramen 500 adjacent the treatment site,the probes are inserted radially away from, for example lateral, caudalor cephalad to, the lateral edge of a foramen, for example about 8 toabout 12 mm, for example about 10 mm, from the lateral edge. Thesepositions may or may not lie within the sacral neural crescent. Probes400 should be placed at the 2 o′clock, 4 o′clock and 6 o′clock positionsradially away from the lateral edge of a foramen when the foramen isviewed as a clock face. Alternatively, 2 probes 400 may be used and theymay be placed at, for example, the 3 o′clock and 5 o′clock positions. Inother embodiments, other numbers of probes may be used, and they may beat various positions around the foramen, and the invention is notlimited in this regard.

In one embodiment of this aspect of the present invention, threeintroducers are inserted into a patient's body from an approach that maybe substantially perpendicular to the surface of the target treatmentsite adjacent the foramen, such that a distal end of each introducer ispositioned proximate to or adjacent the lateral edge of sacral foramen500, or the sacral neural crescent 506. In some embodiments, the distalends of the introducers and/or probes are positioned substantiallysuperficial to the sacral bony surface, such that, in particularembodiments, there are no ligaments or other connective tissue betweenthe distal end and the sacrum. In further embodiments, the distal endsof the introducers and/or the probes may be placed about 2 to about 6 mmaway from the surface of the sacrum, for example about 4 mm away fromthe surface. For example, an introducer apparatus may be about 2 toabout 6 mm longer than a probe such that, when a distal end of theintroducer is placed adjacent to the surface of the sacrum, the distalend of a probe disposed within the introducer may be located about 2 toabout 6 mm away from the surface. In other embodiments, various anglesof approach and sites of entry may be used. Depending on the site ofentry and the angle of approach that are chosen, the introducer may beeither bent or straight. A bent introducer may take several forms andthe invention is not limited in this regard. For example, it may be bentalong a substantial portion of its length or it may have a bent tip,wherein the rest of the introducer may be straight. At this point, theposition of one or more introducers may be verified using fluoroscopicimaging (or other imaging modalities) or other means, after which theprobes may be inserted through a bore or lumen of each introducer. Theprobes may be positioned at an angle such that the target treatment siteis visualized straight down the shaft of the probes, and the probes mayappear in cross-section, as shown in FIG. 5. It should be noted that, inthose embodiments that comprise a stylet to facilitate positioning ofthe probe, the stylet may be disposed within an introducer and may beremoved from the introducer prior to insertion of the probe.

As mentioned above, it may be advisable, at this stage, to ascertain thelocation of one or more of the probes with respect to any sensory and/ormotor nerves that may be located close to the conductive regions of theprobes by stimulating the neural tissue at one or more frequencies anddetermining the effect of said stimulation, as has been described. Thestimulation of neural tissue may be performed in a monopolar manner,wherein energy passes between one or more probes and a dispersive returnelectrode. Using this step, it can be determined whether a target nerveor nerves has a function that would contraindicate its ablation orfunctional alteration. In this embodiment, the lack of acontraindication would lead to the step of delivering energy, whereasthe presence of a contraindication would lead back to the step ofinserting a probe or probes, whereby the step of inserting a probe orprobes comprises modifying the position of a probe or probes within thebody. In alternate embodiments, no stimulation is performed and a usermay rely on his or her knowledge to determine whether or not to proceedwith the treatment procedure.

At this point, energy may be delivered from energy source 206 via theprobes to the target treatment site. Referring still to FIG. 5B, energymay be delivered in order to create a lesion lateral to foramen 500,such that the lesion may, in some embodiments, encompass at least onesacral nerve exiting foramen 500 and/or one or more lateral branches ofthe sacral nerve. For example, in embodiments utilizing monopolar RF, asubstantially spherical lesion, for example an oblate or prolatespheroid, may form around each probe, which may result in a totaleffective lesion 504 as shown in FIG. 5B. A portion of lesion 504 mayform due to conduction of energy through the tissue, rather than due todirect delivery of energy from probe 400. In some embodiments, thelesion may have a height of about 1 mm to about 15 mm, for example about8 mm to about 10 mm, in order to account for variability in the locationof the nerves to be treated. In some embodiments, the user may adjust aparameter of the treatment procedure in order to modify the height ofthe lesion, and thereby increase the size of the lesion, as describedherein above. As will be described below, energy delivery to the probesmay be substantially concurrent or it may be sequential, depending, forexample, on the number of probes used, the energy source 206 and thepreferences of the user.

Following the step of energy delivery, if one or more of the probes aresteerable, the tips of one or more of the probes may be maneuvered to asecond location and energy may again be delivered to ablate the neuraltissue at the second location. This may be repeated as many times as theuser feels is necessary. If no probes are steerable, the insertion andpositioning steps may be repeated so that one or more of the probes isremoved and reinserted to a second position, at which point energy maybe delivered again at this location. For example, in some embodiments,only one probe may be used. In such embodiments, the probe may be placedat a first position adjacent to the foramen as indicated above, forexample at the 4 o′clock position. After energy delivery has beencompleted at this position, probe 400 may be removed and reinserted intothe 2 o′clock position and the energy delivery step may be repeated.Subsequently, the probe may be removed and reinserted into the 6 o′clockposition and the energy delivery step may again be repeated.Alternatively, rather than being removed and reinserted, the probe mayinstead be repositioned while remaining within the patient's body. Forexample, a probe 400 may be inserted, in some embodiments with anintroducer, at the 4 o′clock position, at which point energy may bedelivered. Subsequently, the position of the same probe may be adjustedsuch that the distal tip lies substantially at the 2 o′clock positionand energy delivery may be repeated. Similarly, the probe position maythen be adjusted, for example without removing the probe from thepatient's body, such that the distal tip lies substantially at the 6o′clock position and energy may again be delivered. It should be evidentthat the specific order of the probe positions may be varied; forexample, the probe may initially be placed at either the 2 o′clock or 6o′clock positions and subsequent reinsertions may be at any of the othertwo positions. In some specific embodiments, for example when anestheticis supplied to the target site, it may be desirable to position theprobes in an order that accounts for the drift of the anesthetic. Forexample, if the anesthetic is expected to drift cranially, it may bebeneficial to first place a probe at the 2 o′clock position and proceedcaudally to the 4 o′clock and 6 o′clock positions. Once the user hasdetermined that enough neural tissue has been ablated, the introducerand the probe may be removed from the body and the patient should beallowed to recover. It should be noted that this description is intendedto be exemplary only and that other embodiments are envisioned as well.In addition, this invention is not intended to be limited by the numberand type of probes used in this and other embodiments.

During the step of inserting the probe(s), the position of the probe(s)or introducer(s) may be visualized and/or monitored, for example byusing fluoroscopy or other imaging modalities. If fluoroscopy is used,visualization may be improved by incorporating radio-opaque markers ontoone or more of the probe(s) or introducer(s) and/or by injectingradiopaque dye into the patient's body. In some embodiments, radiopaquemarkers may be incorporated onto a distal region of the probe(s) inorder to determine the distance that the probe(s) are extending out ofthe introducer(s). In addition, visual depth markers may be used to helpdetermine the position of the probe(s) or introducer(s) within the body.Furthermore, positioning may be confirmed by measuring the impedance oftissue at the location of the probe(s) or introducer(s). In someembodiments, insertion and positioning are beneficially aided by thestimulation of tissue. Stimulation energy is delivered to the targetsite via one or more probes at a frequency sufficient to cause musclecontraction, nociceptive sensation, or other physiological response. Inaddition, some embodiments of the present invention may comprise one ormore stylets having electrical connections such that the one or morestylets may be operatively connected to the energy source 206. In suchembodiments, stimulation energy may be delivered to the target site viathe one or more stylets prior to removal of the stylets and insertion ofthe probes. The effects of stimulation are sensed by one or more sensingmeans or, additionally or alternatively, by observation. In someembodiments, positioning may not be verified using these means and auser may rely in whole or in part on his knowledge of a patient'sanatomy in order to accurately place the device(s).

Referring now to the step of delivering energy through the probe(s),this may be accomplished by providing an energy source 206, operable todeliver radiofrequency (RF) energy; connecting energy source 206 to theprobe(s); and operating energy source 206 to deliver RF energy to thetissue through an energy delivery means, for example a conductive regionassociated with a distal region of the probe(s), such as an active tipor active electrode. In one embodiment, energy source 206 is operable todeliver sufficient energy to the tissue through the probe(s) so that thetissue may be ablated, as has been mentioned. Energy source 206 may beoperable to be concurrently coupled to all of the probes used to deliverenergy to the patient's body during the course of the treatmentprocedure. As mentioned above, in some embodiments, one or more probesmay be ‘on’ (i.e. transmitting or receiving current) at a given point intime while other probes are ‘off’ (i.e. not transmitting or receivingcurrent), while in other embodiments all probes may be transmitting orreceiving current substantially concurrently.

Ablation of the dorsal sacral nerves exiting laterally from the sacralforamina by the creation of a lesion may prevent the transmission ofpain sensations. In some embodiments, RF energy may be delivered in aseries of amplitude or frequency modulated pulses, whereby tissueheating is inhibited by interrupting periods of energy delivery from oneor more probes with relatively long periods in which no energy isdelivered via the one or more probes. As has already been mentioned, insome embodiments the probes may be pulsed sequentially, such that whileone probe is delivering energy another probe is not. This interrupteddelivery would allow heat to dissipate further radially from theun-insulated tip without causing local coagulation (during the no energydelivery stage). Subsequent durations of the energy delivery stage wouldprovide necessary heating of tissue and effectively created a virtual“cooled lesion”, i.e. a larger lesion than may be achieved using anun-cooled probe and uninterrupted energy delivery. Furthermore, somemethods of treatment involve delivering energy to achieve a differenteffect, for example, increasing collagen production, remodelingcollagen, up-regulation of heat-shock proteins, alteration of enzymes,and alteration of nutrient supply. In further embodiments, a generatormay not be used. In these embodiments, energy source 206 may take theform of a battery, in which case the entire apparatus (probe and energysource 206) may be hand-held/portable/modular, or any other energysource 206, and the invention is not limited in this regard. Tosummarize, any delivery of energy that may result in a treatment effectis intended to be included within the scope of this aspect of thepresent invention.

Regarding connecting energy source 206 to the probe(s), in someembodiments, energy source 206 may be releasably coupled to theprobe(s). For example, this may be achieved by providing releasableelectrical connectors 310 at or proximate to the proximal region of theprobe(s) or at a proximal end of a cable or other connecting meanscoupled to the probe(s). In embodiments in which the probe(s) arecooled, the proximal region of the probe(s) may further comprisereleasable connectors, such as Luer lock fittings for example, to coupleone or more cooling means, such as peristaltic pumps and associatedtubing, to the probe(s). In alternate embodiments, the probe(s) may bepermanently coupled to the energy source 206 and/or the one or morecooling means.

In one embodiment of this aspect of the present invention, the methodmay further comprise a step of moving the probe(s) to another locationwithin the tissue if the user so desires. The probe(s) may be movedbefore, during, or after the step of delivering energy, and may be movedone or more times. The step of moving the probes may comprise one ormore of the following actions: applying a force to bend one or more ofthe probes within the tissue (wherein the probe may thus be described asa ‘steerable’ probe), moving one or more of the probes intact within thetissue, removing one or more of the probes intact from the tissue,reinserting one or more of the probes into the tissue and moving one ormore parts of the probe (for example, extending or retracting asegmented probe telescopically) to move the position of one or morefunctional elements within the tissue.

In alternate embodiments of this aspect of the present invention, energymay be delivered in forms other than radiofrequency electrical energy,including but not limited to: other forms of electromagnetic energy,thermal energy, optical energy, mechanical energy and ultrasonic energy.Additionally, the step of delivering energy could involve the use ofother energy delivery devices including, but not limited to: microwaveprobes, optical fibers, resistive heaters, and ultrasoundemitters/transducers.

As was mentioned briefly above, the step of delivering energy to thetissue, may involve, in some embodiments, the use of apparatuses inwhich any of the one or more probes are actively or passively cooled.Cooling of probes can prevent the searing or coagulation of tissuedirectly adjacent to the probe(s) and can prevent the vaporization ofliquid within the tissue. Cooling can also be used to increase themaximum lesion volume that can be formed in a given tissue. In oneembodiment using three probes, as described above with reference to FIG.4A, probe 402, having a relatively larger conductive region and servingas the effective return electrode for both probes 400, may have a highdegree of cooling since it would normally tend to have the highesttemperature, while probes 400 may have a relatively low degree ofcooling in order to avoid tissue charring and popping adjacent theprobes. The degree of cooling may be affected by, for example, thetemperature of a fluid used to cool the probes and/or the flow rate ofthe fluid through the probes. In another embodiment, higher cooling maybe supplied to probes at the 2 o′clock and 6 o′clock positions, withlower cooling being supplied to the probe at the 4 o′clock position.Alternatively, the degree of cooling may be substantially equivalent forall of the probes. In addition, the degree of cooling may be fixed orvariable during the course of a treatment procedure for any of theprobes.

In some embodiments, cooling may be shared between two or more probes,such that the cooling output of one probe is the cooling input ofanother. Such a configuration could beneficially allow cooling ofmultiple probes without requiring an individual cooling supply, such asa pump, for each probe. For example, in an embodiment using 3 probes,such as that shown in FIG. 4A whereby energy is delivered between twoprobes 400 and a single probe 402, the pair of probes 400 may share acooling source, and the single probe 402 may have a separate coolingsource. Using cooling in conjunction with monopolar energy delivery mayallow for more precise control of lesion size than may be possible whendelivering energy in a bipolar configuration. This may be due to thefact that the cooling of each monopolar probe may be independentlycontrolled while the cooling of each of the bipolar probes may bedependent upon the other bipolar probe in order to maintain theeffective flow of current between the probes. In addition, cooling maybe used to project a lesion away from the probe(s) as has been mentionedabove.

In addition to optionally measuring impedance, as in the embodimentdescribed above, some embodiments further comprise an additional step ofmeasuring the temperature of tissue at least at one location. This maybe desirable so as to ensure that a given region of tissue is notexceeding a certain temperature. For example, in some embodiments it maybe desirable to maintain the temperature of tissue at or below atemperature required for neural ablation, for example about 42.degree.C. In some embodiments, a temperature monitoring means may be located onor within a distal region of the one or more probes and the temperatureof tissue located proximate to the distal region(s) of one or more ofthe probe(s) may be monitored using the temperature monitoring means.Temperature measurements may be averaged or otherwise combined from twoor more probes or each probe may be monitored independently.Alternatively or in addition, a temperature monitoring means may belocated at a different location on the one or more probe(s) to monitorthe temperature of a region of tissue located some distance away fromthe distal region(s) of the probe(s). Furthermore, one or more separatetemperature monitoring means may be inserted into the patient's body inorder to monitor the temperature of one or more specific regions oftissue. The temperature monitoring means may take the form ofthermocouples, thermistors, optical thermal sensors or any othertemperature sensing or monitoring means and the invention is not limitedin this regard. The temperature monitoring means may be connecteddirectly to the energy source 206 (e.g. the RF generator) or to acontroller associated with energy source 206. Alternatively, thetemperature monitoring means may be monitored by an independenttemperature monitoring device. These embodiments are intended to beexemplary only and are not intended to limit the present invention inany way.

As a feature of this aspect of the present invention, embodiments ofthis method may further comprise one or more steps of modifying atreatment procedure in response to one or more measured parameters.These measured parameters may include, but are not limited to,temperature, position of the probe(s) or impedance. For example, if atemperature measurement is determined to be outside of a desired range,a treatment procedure may be modified by, for example, altering theamount of energy delivered by energy source 206, modifying or modulatingthe one or more cooling means in some way, or terminating the procedure.In one embodiment of the present invention described above (and shown inFIGS. 4A and 5A), a temperature measurement from a probe 402 having alarger conductive region 306 may be used to control energy deliverywhile temperature measurements from probes 400 may be used to ensurepatient safety. As another example, the amount of energy delivered bythe energy source 206 may be modified based on the position of the oneor more probes (for example, depending on the distance between a probeand the target treatment site or on the distance between the probesthemselves when more than one probe is used). In such embodiments,wherein a treatment procedure may be modified, a feedback apparatus maybe associated with or incorporated into the energy source so that anymodification of a treatment procedure in response to a measuredparameter may occur automatically, without any input from a user. Inother embodiments, there may not be an automatic feedback apparatus inplace, in which case a user may manually modify a treatment procedure inresponse to a measured parameter. In addition to modifying a treatmentprocedure based on measured parameters, this invention also provides fora step of determining the initial parameters to be used in a treatmentprocedure (for example, the initial maximum power level or tissuetemperature, temperature ramp rate, etc.) using information that isknown about the particular tissue to be treated. For example, ifpre-treatment testing reveals specific information about the sacrum of aparticular patient (this information may include, but is not limited to:the topology of the sacrum, location of specific nerves, etc.), thatinformation may be used to decide on what parameters to use initiallyfor the treatment procedure.

In some embodiments of this aspect of the present invention, the step ofperforming a treatment operation in order to reduce pain may comprisethe addition or removal of material to or from the body. Material thatmay be added to the region of tissue being treated includes, but is notlimited to, alcohol, chemical lysing agents, pharmaceutical agents orcontrast media. Material that may be removed from the region of tissuebeing treated includes, but is not limited to, ligamentous tissue orother connective tissue. The removal of material may be accomplishedthrough various means, which can include aspiration, vaporization and/ormechanical conveyance. Furthermore, the steps of addition and removal ofmaterial can be performed concurrently, for example by irrigating thetissue with a liquid medium while aspirating the liquid effluent. Theaddition or removal of material may also be combined with the deliveryof energy, as has described above, wherein the delivery of energy andthe addition or removal of material may occur concurrently orsequentially.

In an alternate embodiment of a method aspect of the present invention,probes may be inserted to the target site using different approaches.For example, it may be beneficial to insert the probes at a differentangle with respect to the surface of patient's body. In one alternateembodiment, for example when using the probes in a bipolarconfiguration, it may be useful to follow a ‘leapfrog’ approach, whereinthe probes are inserted to initial locations and a lesion is createdbetween the probes. Once at least one lesion is created, one probe isrepositioned with respect to a second probe, for example moresubstantially cranially along the sacrum lateral to the posteriorforamen, and another lesion is created. Following this, the second probeis repositioned so as to be located on the other side of the firstprobe, even more substantially cranially along the sacrum, and so on.This method can also be practiced by using a multiplicity of probes andleaving each probe in place. In other words, once a probe is in place itmay remain there and further probes may be inserted in order to achievethis ‘leapfrog’ lesioning approach. In other embodiments, both bipolarand monopolar configurations may be used in conjunction with variousother approaches.

Although embodiments of the method aspect of the present invention hasbeen described with respect to one specific application, i.e. treatmentof SIJS, it should be evident that the apparatus and method disclosedherein may be used to treat various other conditions at various othertreatment sites within a patient's body. As such, the embodiments of thevarious aspects of the invention described above are intended to beexemplary only. The scope of the invention is therefore intended to belimited solely by the scope of the appended claims.

It is appreciated that certain features of the invention, which are, forclarity, described in the context of separate embodiments or separateaspects, may also be provided in combination in a single embodiment.Conversely, various features of the invention, which are, for brevity,described in the context of a single embodiment or aspect, may also beprovided separately or in any suitable sub-combination.

Although the invention has been described in conjunction with specificembodiments thereof, it is evident that many alternatives, modificationsand variations will be apparent to those skilled in the art.Accordingly, it is intended to embrace all such alternatives,modifications and variations that fall within the spirit and broad scopeof the appended claims. All publications, patents and patentapplications mentioned in this specification are herein incorporated intheir entirety by reference into the specification, to the same extentas if each individual publication, patent or patent application wasspecifically and individually indicated to be incorporated herein byreference. In addition, citation or identification of any reference inthis application shall not be construed as an admission that suchreference is available as prior art to the present invention.

What is claimed is:
 1. A method of treating at least one target site ina sacroiliac region of a patient's body by delivering energy, thesacroiliac region including a sacrum having a posterior surface and aplurality of foramina extending therethrough, and a sacral neuralcrescent adjacent the foramina, each of the foramina defining a face ina plane generally parallel to the opening defining the foramina, themethod comprising the steps of: inserting one or more probes into thesacroiliac region of a patient's body, wherein the one or more probesare inserted so as to be generally upstanding relative to a portion ofthe posterior surface of the sacrum laterally adjacent a face of atleast one of the foramina, the one or more probes being inserted so thatenergy is delivered to at least one of approximately 2 o′clock, 4o′clock and 6 o′clock positions lateral to the face of one of theforamina, or at least one of approximately 10 o′clock, 8 o′clock and 6o′clock positions lateral to the face of one of the foramina, when oneof the foramina is viewed as a clock face with 12 o′clock in the cranialdirection; and delivering energy from an energy source through the oneor more probes to the at least one target site.
 2. The method of claim1, further comprising inserting the one or more probes at an angleranging between about 45° to about 135° from a line perpendicular to aface of at least one of the foramina relative to the portion of theposterior surface.
 3. The method of claim 2, further comprisinginserting at least one of the one or more probes at an angle rangingbetween about 60° to about 120° from the line.
 4. The method of claim 3,further comprising inserting at least one of the one or more probes atan angle ranging between about 80° to about 100° from the line.
 5. Themethod of claim 1, further comprising inserting at least one of the oneor more probes such that at least a portion of the target site isgenerally distal to the distal end of the at least one probe.
 6. Themethod of claim 1, wherein the at least one target site is located atleast 1 cm lateral to a face of one of the foramina.
 7. The method ofclaim 1, further comprising cooling at least one of the one or moreprobes.
 8. The method of claim 1, further comprising delivering theenergy in at least one of a monopolar, bipolar, multipolar, or triphasicmanner.
 9. The method of claim 1, further comprising positioning atleast one of the one or more probes such that it is substantiallyperpendicular to the sacrum.
 10. The method of claim 1, furthercomprising: repositioning at least one of the one or more probes to arepositioned site; and delivering the energy from the energy sourcethrough the at least one of the one or more probes at the repositionedsite.
 11. The method of claim 1, further comprising forming a lesion inat least a portion of the at least one target site via the deliveredenergy.
 12. The method of claim 11, further comprising adjusting aparameter of a treatment procedure, wherein a size of the lesion isincreased.
 13. The method of claim 12, wherein adjusting the parameterof the treatment procedure comprises repositioning at least one of theone or more probes to alter a distance between the one or more probesand the at least one target site.
 14. The method of claim 12, whereinadjusting the parameter of the treatment procedure comprises adjusting alength of an electrically exposed conductive region of at least one ofthe one or more probes.
 15. The method of claim 12, wherein adjustingthe parameter of the treatment procedure comprises modifying an amountof cooling supplied to at least one of the one or more probes.